Recommendations for Investigational and Licensed COVID-19 Convalescent Plasma Guidance for Industry July 2024

GUIDANCE DOCUMENT

• Docket Number: FDA-2024-D-2442
• Issued by: Center for Biologics Evaluation and Research

This guidance provides FDA’s recommendations to blood establishments for the submission of a Biologics License Application (BLA) for the manufacture of COVID-19 convalescent plasma for transfusion intended to treat patients with immunosuppressive disease or receiving immunosuppressive treatment in either the outpatient or inpatient setting. The guidance also provides FDA’s recommendations for Investigational New Drug applications (INDs) for investigational COVID-19 convalescent plasma for transfusion.

FDA is implementing this guidance without prior public comment because the Agency has determined that prior public participation is not feasible or appropriate (see 21 CFR 10.115(g)(2) and (g)(3)). FDA made this determination because we recognize that SARS-CoV-2 continues to circulate and COVID-19 remains a serious health risk, especially for patients with immunosuppressive disease or receiving immunosuppressive therapy. FDA’s recommendations on the development of drugs and biological products for treatment and prevention of COVID-19 is necessary to address an unmet public health need.

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You can submit online or written comments on any guidance at any time (see 21 CFR 10.115(g)(5))

If unable to submit comments online, please mail written comments to:

Dockets Management
Food and Drug Administration
5630 Fishers Lane, Rm 1061
Rockville, MD 20852

All written comments should be identified with this document's docket number: FDA-2024-D-2442.

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